FDA Delays Eli Lilly’s Orforglipron Ruling to April, Shares Fall
Eli Lilly’s FDA decision for its obesity drug orforglipron has been delayed two months to April, extending the review period into Q2 and granting Novo Nordisk additional lead time in the weight-loss market. Shares slipped on the report as orforglipron’s approval timing is now less certain, potentially affecting sales projections.
1. Eli Lilly Launches $1 Billion AI Research Lab with Nvidia
On January 12, Eli Lilly announced a five-year partnership with Nvidia to establish an AI innovation lab in the San Francisco Bay Area, with combined investment of up to $1 billion. The facility will house Lilly researchers alongside Nvidia engineers to develop advanced machine-learning models aimed at reducing the time and cost of drug discovery. This follows last year’s launch of the industry’s most powerful pharmaceutical supercomputer—also built with Nvidia technology—and the introduction of TuneLab, a free AI-driven discovery platform for smaller biotech firms. By leveraging its extensive clinical-trial database and Nvidia’s Vera Rubin AI chips, Lilly aims to accelerate identification of novel compounds and improve candidate success rates in early-stage development.
2. Weight Management Franchise Fuels 54% Revenue Surge
In the third quarter, Eli Lilly’s revenue climbed 54% year-over-year to $17.6 billion, driven largely by tirzepatide—marketed for weight loss under the brand name Zepbound—which became the world’s best-selling drug. EPS reached $6.21, up 480% from the prior-year period. Analysts expect continued top-line growth through 2030, supported by expanding production capacity and global rollout. Backlog for its obesity and diabetes portfolio remains robust, with orforglipron on track for a regulatory decision later this year and retatrutide delivering strong Phase 3 results in early obesity trials.
3. Pipeline Diversification and Shareholder Returns
Beyond its GLP-1 franchise, Lilly has broadened its pipeline with recent approvals of an eczema treatment, a next-generation Alzheimer’s antibody, and a novel oncology agent. The company’s R&D spend exceeded 24% of sales in 2025, targeting indications in immunology, pain management and rare diseases. Lilly also returned significant cash to shareholders, raising its dividend by 18% last year and achieving a five-year payout growth of 103.5%. With an 83% gross margin and free cash flow generation exceeding $10 billion annually, management has signaled continued dividend hikes and opportunistic share repurchases alongside strategic biotech acquisitions.